Bonefos and the Consumption of Analgesics

Completed

• Conditions: Bone Neoplasms
• Interventions: Drug: Bonefos (Clodronate, BAY94-8393)

• Registration Number: NCT00909142
• Lead Sponsor: Bayer

Brief Summary

The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2007-04
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Study First Submitted: 2009-05-25
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Breast cancer or prostate cancer or multiple myeloma.
• Bone metastasis.
• Ability to use analgesics and clodronate 1600 mg/day.

Read More

Exclusion Criteria

• Hypersensitivity to bisphosphonates.
• Clodronate in previous therapy.
• Concomitant use of other bisphosphonates.
• Serious renal insufficiency.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	Bonefos (Clodronate, BAY94-8393)	-

Primary Outcome Measures

Name	Time	Method
Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma	12 months

Secondary Outcome Measures

Name	Time	Method
Decrease in pain measured by VAS (Visual Analogue Scale)	12 months